FDA 510(k) Application Details - K151874

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K151874
Device Name Ventilatory Effort Recorder
Applicant Salter Labs
2365 Camino Vida Roble
Carlsbad, CA 92011 US
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Contact Mara Caler
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 07/09/2015
Decision Date 04/15/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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